| Product |
Company |
Generic name |
KEGG DRUG |
|
POTASSIUM PHOSPHATES solution, concentrate 224 mg/mL (ANDA)
|
Amneal Pharmaceuticals Private Limited |
potassium phosphate, monobasic potassium phosphate, dibasic injection, |
|
|
GABAPENTIN capsule 100 mg (ANDA)
|
REMEDYREPACK INC. |
GABAPENTIN |
D00332
|
|
Flucelvax injection, suspension 15 ug/.5mL (BLA)
|
ASCLEMED USA INC. |
INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
D04536
|
|
Primidone tablet 50 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Primidone |
D00474
|
ZOLPIDEM TARTRATE tablet 5 mg (ANDA)
ZOLPIDEM TARTRATE tablet 10 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
zolpidem tartrate |
D00706
|
|
Sildenafil tablet, film coated 100 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Sildenafil |
D02229
|
|
pantoprazole sodium injection, powder, for solution 40 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
pantoprazole sodium |
D02593
|
|
acyclovir ointment 50 mg/g (ANDA)
|
Torrent Pharmaceuticals Limited |
acyclovir |
D00222
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 7.5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Procainamide Hydrochloride injection 100 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Procainamide Hydrochloride |
D00477
|
Sildenafil tablet, film coated 25 mg (ANDA)
Sildenafil tablet, film coated 50 mg (ANDA)
Sildenafil tablet, film coated 100 mg (ANDA)
|
Jubilant Cadista Pharmaceuticals Inc. |
sildenafil |
D02229
|
|
Cholestyramine powder, for suspension 4 g/9g (ANDA)
|
AiPing Pharmaceutical, Inc. |
Cholestyramine |
D02690
|
|
Meclizine Hydrochloride tablet 25 mg (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
Meclizine Hydrochloride |
D01317
|
|
ITRACONAZOLE capsule 100 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
itraconazole |
D00350
|
Tofacitinib tablet, film coated 5 mg (ANDA)
Tofacitinib tablet, film coated 10 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Tofacitinib |
D09783
|
|
Rifabutin capsule 150 mg (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
rifabutin |
D00424
|
|
CLOFARABINE injection 1 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
CLOFARABINE |
D03546
|
MOVANTIK tablet, film coated 12.5 mg (NDA)
MOVANTIK tablet, film coated 25 mg (NDA)
|
Averitas Pharma, Inc. |
naloxegol oxalate |
D10375
|
|
Fludarabine Phosphate injection, solution 25 mg/mL (ANDA)
|
Hisun Pharmaceuticals USA, Inc. |
Fludarabine Phosphate |
D01907
|
|
Fluconazole tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Fluconazole |
D00322
|
|
Haloperidol Decanoate injection 100 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Haloperidol Decanoate |
D01898
|
BENLYSTA solution 200 mg/mL (BLA)
BENLYSTA injection, powder, lyophilized, for solution 120 mg.5mL (BLA)
BENLYSTA injection, powder, lyophilized, for solution 400 mg/5mL (BLA)
|
GlaxoSmithKline LLC |
belimumab |
D03068
|
|
Cyclobenzaprine Hydrochloride capsule, extended release 15 mg (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
TOFACITINIB solution 1 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
TOFACITINIB |
D09783
|
|
RALDESY TM solution 10 mg/mL (NDA)
|
Validus Pharmaceuticals LLC |
TRAZODONE HYDROCHLORIDE ORAL |
D00820
|
|
SENSORCAINE injection, solution 5 mg/mL (ANDA)
|
Sportpharm LLC |
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE |
D11569
|
AMRIX capsule, extended release 15 mg (NDA)
AMRIX capsule, extended release 30 mg (NDA)
|
Cephalon, LLC |
Cyclobenzaprine Hydrochloride |
D00772
|
|
EPLERENONE tablet, film coated 25 mg (ANDA)
|
American Health Packaging |
EPLERENONE |
D01115
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Ibuprofen |
D00126
|
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Tadalafil |
D02008
|
Pomalidomide capsule 1 mg (ANDA)
Pomalidomide capsule 2 mg (ANDA)
Pomalidomide capsule 3 mg (ANDA)
Pomalidomide capsule 4 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Pomalidomide |
D08976
|
METFORMIN HYDROCHLORIDE tablet, extended release 500 mg (ANDA)
METFORMIN HYDROCHLORIDE tablet, extended release 750 mg (ANDA)
|
Marlex Pharmaceuticals, Inc. |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Gabapentin capsule 100 mg (ANDA)
|
REMEDYREPACK INC. |
Gabapentin |
D00332
|
|
Famotidine tablet, film coated 20 mg (ANDA)
|
Major Pharmaceuticals |
Famotidine |
D00318
|
|
Oseltamivir Phosphate powder, for suspension 6 mg/mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Oseltamivir Phosphate |
D00900
|
|
SIMVASTATIN tablet, film coated 20 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
SIMVASTATIN |
D00434
|
|
Enalapril Maleate tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
Enalapril Maleate |
D00621
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
REMEDYREPACK INC. |
Ibuprofen |
D00126
|
|
Ondansetron tablet, film coated 8 mg (ANDA)
|
REMEDYREPACK INC. |
Ondansetron |
D00678
|
|
Ofloxacin Otic solution 3 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Ofloxacin |
D00453
|